INCB 50465-204 (CITADEL-204) (R/R)
A Phase 2, Open-Label, 2-Cohort Study of INCB050465, a PI3Kδ inhibitor, in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (MZL) With or Without Prior Exposure to a BTK Inhibitor (CITADEL-204)
- Experimental arm: cohort 1: Participants who have received prior ibrutinib: INCB050465 at protocol-defined dose
- Experimental arm: cohort 2: Participants who have not received a prior BTK inhibitor: INCB050465 at protocol-defined dose
- Age ≥ 18 years
- Histologically confirmed marginal zone lymphoma, including extranodal, nodal and splenic subtypes
- Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1,5 cm in the longest transverse diameter and ≥ 1.0 cm in the longest perpendicular diameter.
- ECOG score of 0-2
- Evidence of diffuse large B-cell transformation
- History of central nervous system lymphoma or leptomeningeal disease
- Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K inhibitor.
- Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment.
- Active graft versus host disease.
- Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation.
- University Hospital Leuven Gasthuisberg
- Cliniques Universitaires UCL Saint Luc